ALISO VIEJO, Calif., Jan. 17, 2008 (PRIME NEWSWIRE) -- SenoRx, Inc. (Nasdaq:SENO) today announced that it has launched Contura(tm), its Multi-Lumen Balloon (MLB) Catheter for delivering brachytherapy to the surgical margins following lumpectomy for breast cancer. The company had previously said that it intended to transition from user preference testing, which had expanded to 34 clinical sites by the end of 2007, to full commercial launch in January 2008.
Contura is one of a new class of devices which is designed to reduce radiation treatment time to five days from six to eight weeks in patients eligible for the treatment. SenoRx believes that the Contura MLB can play an important role in the shift from traditional whole breast radiation therapy to localized partial breast radiation therapy. Some patients who are presently candidates for balloon therapy are currently excluded because of the location of the lesion and their breast size. Contura's advanced multi-lumen design may address this issue for certain patients. In addition, the Contura MLB uses vacuum suction to remove excess seroma and air to enhance conformance of often irregularly shaped lumpectomy cavity walls to the balloon surface in order to deliver precise radiation dosing through multiple radiation source lumens. SenoRx has been granted three patents related either to the design or manufacturing of Contura and has additional patents pending.
"Since the 510(k) clearance from the U.S. Food and Drug Administration on May 23, 2007, the positive feedback that we have gathered for Contura during the pre-launch evaluation conducted in the second half of the year has strengthened our belief that its innovative multi-lumen design, along with the vacuum feature and its propriety manufacturing process, can provide the clinical advantages we had hoped to achieve," said Lloyd Malchow, SenoRx President and Chief Executive Officer. "We are further pleased that several clinical sites have already submitted papers and abstracts for presentation at upcoming oncology meetings."
SenoRx recently provided its initial estimate for 2008 revenues for all of its product lines, which is expected to be in a range of $46 million to $50 million.
About SenoRx
SenoRx (Nasdaq:SENO) develops, manufactures and sells minimally invasive medical devices used by breast care specialists for the diagnosis and treatment of breast cancer, including its flagship EnCor(r) system and Contura(tm) MLB. SenoRx's field sales organization serves over 1,000 breast diagnostic and treatment centers in the United States and Canada. With 18 products having received FDA 510(k) clearance across the continuum of breast care, SenoRx is developing additional minimally invasive products for diagnosis and treatment of breast cancer. For more information, visit the company's website at www.senorx.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Specifically, statements concerning the expected clinical advantages of Contura(tm) MLB and the company's financial guidance are forward-looking statements within the meaning of the Safe Harbor. Forward-looking statements are based on management's current, preliminary expectations and are subject to risks and uncertainties, which may cause SenoRx's actual results to differ materially from the statements contained herein. Information on potential risk factors that could affect SenoRx's business and its financial results are detailed in its most recent quarterly report on Form 10-Q, as filed with the Securities and Exchange Commission. Undue reliance should not be placed on forward-looking statements, especially guidance on future financial performance, which speaks only as of the date they are made. SenoRx undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date they were made, or to reflect the occurrence of unanticipated events.
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